ppArrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them.
Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes.
RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein.
Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
/p pArrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease.
The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics.
Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
/p pArrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI San Diego, CA, and a state of the art manufacturing facility in Verona, WI.
Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
/p h3The Position /h3 pThis position serves as a individual contributor within the Quality Assurance department, supporting the change management process within the Quality Management System (QMS) for Arrowhead's preclinical, clinical, and commercial programs.
The role will support change control activities for regulated processes and systems, equipment and instruments, computerized systems, products and specifications, manufacturing processes, analytical methods, suppliers,



and related regulatory documentation.
This includes supporting risk assessment activities performed as part of the change management process.
The Senior QA Specialist partners with internal departments and cross-functional teams to ensure proposed changes are appropriately assessed for impact, implemented in a controlled manner, and verified for effectiveness.
/p h3Responsibilities /h3 ul liSupport assigned components of the QMS change control system, including facilitating the review, processing, and disposition of change requests for completeness, accuracy, and procedural compliance.
/li liCoordinate and support Change Control Board (CCB) meetings, including agenda preparation, minutes, and tracking of follow-up action items to closure.
/li liSupport cross-functional assessments of proposed changes, working with stakeholders to evaluate impact and confirm appropriate action plans and effectiveness checks are established and completed.
/li liSupport risk assessment activities conducted as part of the change management process, partnering with cross-functional stakeholders to identify, evaluate, and document quality and compliance risks associated with proposed changes.
/li liMaintain and update CCB schedules and dashboards for the QMS and specified functional areas.
/li liConduct quality review and disposition of change controls and effectiveness checks for accuracy, completeness, and alignment with regulatory requirements and business needs prior to escalation for approval.
/li liCompile metrics and prepare reports on change management activities for review boards and in support of annual product quality reviews.




/li liTrain and coach stakeholders on change management processes within the QMS to promote consistency and drive quality culture.
/li liSupport internal audits, regulatory inspections, and third-party audits as a subject matter resource for change management processes.
/li liDrive continuous improvement of QMS processes, documentation, tools, and workflows related to change management.
/li liWriting, review, change control, approval, issuance, and organization of applicable procedural documents (such as policies, SOPs, work instructions, or forms) utilizing existing templates.
/li liAdditional duties as assigned.
/li /ul h3Requirements /h3 ul liMinimum of a bachelor's degree in a science discipline, or equivalent required.
/li liMinimum of five (5) years of experience working in a regulated environment, with preference to quality assurance, change management, and/or risk management experience or equivalent required.
/li liWorking knowledge of FDA, EU, and ICH GxP regulations and guidance.
/li liExcellent written and verbal communication skills and ability to communicate effectively with internal and external parties.
/li liDemonstrated ability to coordinate cross-functional activities and drive tasks to completion.
/li liCompetent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet.
/li /ul h3Preferred /h3 ul liAbility to work independently and manage priorities within a fast-paced environment.
/li liDemonstrated ability to coordinate cross-functional activities and drive tasks to completion.
/li liExperience with quality systems supporting GMP regulations (21 CFR Parts 11, 210, 211, QMSR, and EU GMP).
/li liPrior experience with use of an electronic document and quality management system in a regulated environment /li /ul pWisconsin pay range /p p$90,000—$110,000 USD /p pArrowhead provides competitive salaries and an excellent vantaggi package.
/p pCandidates must have current, valid authorization to work in the country where this role is located.
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📌 Senior Qa Specialist, Change Management (Verona)
🏢 Arrowhead Pharmaceuticals
📍 Verona